BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 23402118 · Received October 28, 2025

    Report

    Report Number
    23402118
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    July 31, 2025
    Report Date
    September 29, 2025
    Manufacturer
    UNKNOWN
    Product Code
    JYT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    TIP OF SURGICAL INSTRUMENT BROKE OFF DURING SURGERY. SURGICAL SITE, STERILE FIELD, AND ROOM THOROUGHLY SEARCHED BUT UNABLE TO LOCATE MISSING TIP. XRAY TAKEN AT END OF CASE PER PROTOCOL, RESULTS READ BY RADIOLOGIST AS NEGATIVE FOR RETAINED SURGICAL ITEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2352150 UNKNOWN PICK, MICROSURGICAL EAR JYT UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female